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Adverse Event Rates Change Favorably Over Time for Patients Bridged With the HeartWare Left Ventricular Assist Device

Maltais, Simon*; Aaronson, Keith D.; Teuteberg, Jeffrey J.; Slaughter, Mark S.§; Najjar, Samer S.; Jeevanandam, Valluvan||; Pham, Duc T.#; McGee, Edwin C. Jr.**; Leadley, Katrin††; Kormos, Robert L.

doi: 10.1097/MAT.0000000000000585
Adult Circulatory Support

The HeartWare Ventricular Assist System (HVAD) provides significant improvements in survival and quality of life, and here, we seek to evaluate temporal differences in the adverse event (AE) rates. Patients (n = 382) in the ADVANCE bridge-to-transplant and continued access protocol trial were assessed for bleeding, cardiac arrhythmia, infection, ischemic and hemorrhagic stroke, and right heart failure during predetermined time periods (≤30, >30–180, >180–365, >365–730, >730–1,095 days) after HVAD implant. The Kaplan–Meier survival at 30 days, 6 months, 1, 2, and 3 years was 98%, 90%, 84%, 71%, and 63%, respectively. There were significantly fewer total AEs in days >30–180 (events per patient year [EPPY] = 5.34) compared with the first 30 days post HVAD implantation (EPPY = 30.36; p < 0.0001). The total AE rate in days >180–365 (EPPY = 4.09) was also significantly lower than the event rate in days >30–180 (EPPY = 5.34; p < 0.0001). Incidence of cardiac arrhythmias, infections, strokes, and right heart failure were highest immediately post implant and lower rates occurred after 6 months. After 1 year, all AEs exhibited stable rates that were comparable up to 3 years of support (all p > 0.05). This changing risk over time has clinically meaningful implications toward improving patient management.

From the *Department of Cardiac Surgery, Mayo Clinic Rochester, Rochester, MN; Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, PA; §Division of Cardiothoracic Surgery, University of Louisville, Louisville, KY; MedStar Heart And Vascular Institute, MedStar Washington Hospital Center, Washington, DC; Cardiac and Thoracic Surgery, University of Chicago Medicine, Chicago, IL; #Division of Cardiac Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL; **Heart Transplant & Ventricular Assist Device Program, Loyola University Health System, Maywood, IL; and ††HeartWare Inc., Framingham, MA.

Submitted for consideration July 2016; accepted for publication in revised form April 2017.

Disclosures: S.M. is a consultant for HeartWare Inc. and Thoratec Corp. K.D.A. has research contracts from HeartWare Inc. and Thoratec Corp. that are managed by the University of Michigan. J.J.T. is on the advisory board for HeartWare Inc., Abiomed, and CareDx. J.J.T. is also on the DSMB for Sunshine Heart, CEC for Thoratec Corp., and a speaker for HeartWare Inc. and CareDx. Thoratec Corp., Sunshine Heart Inc., Abiomed Inc., and CareDx Inc. M.S.S. is a consultant or on the advisory board member for HeartWare Inc., Carmat Inc., and Sunshine Heart Inc. S.S.N. receives research support from HeartWare Inc. and is on the advisory board for HeartWare Inc. and XDx Inc. D.T. P. is a consultant for HeartWare Inc. and Thoratec Corp. K.L. is an employee of HeartWare Inc. None of the other authors have a financial relationship with a commercial entity that has an interest in the subject of the presented study or other conflicts of interest to disclose. Preliminary results of this study have been presented at the 2015 International Society of Heart and Lung Transplantation Meeting (Nice, France).

Correspondence: Simon Maltais, Department of Cardiac Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55902. E-mail: Maltais.Simon@mayo.edu.

Copyright © 2017 by the American Society for Artificial Internal Organs